MAUDE Adverse Event Report: TEPHA, INC. - 3005670760 GALAFLEX 3DR; ABSORBABLE MESH

Model Number	100043-05
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Pain (1994)
Date of Event	06/26/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As reported, patient experienced post-op complications of breast pain and mesh was coming through the skin.Limited information is provided.Based on the information provided it cannot be determined if the galaflex device caused or contributed to the patients post operative outcomes.Pain is a known inherent risk of the surgery/use of the device and included as a possible complication in the adverse reaction section of the instructions for use (ifu) supplied with the device.The ifu also states, "bioresorption of the scaffold material will be essentially complete within 18-24 months." note, the date of implant and date of event is estimated as (b)(6) 2020 and (b)(6) 2022 respectively, based on the information available.The information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.Not returned - remains implanted.
Event or Problem Description
As reported, the patient was implanted with galaflex in (b)(6) 2020 added to a breast lift.It was reported that immediately after surgery, the patient experienced constant pain.The patient reported the breast lift failed in regardless of the mesh implant, and over the next few months the mesh was seen above the skin.It was also reported that it remained that way for two years post op and the patient is left with pain.The patient also states that after adding implants it has failed further.
Additional Manufacturer Narrative
As reported, patient experienced post-op complications of breast pain and mesh was coming through the skin.Limited information is provided.Based on the information provided it cannot be determined if the galaflex device caused or contributed to the patients post operative outcomes.Pain is a known inherent risk of the surgery/use of the device and included as a possible complication in the adverse reaction section of the instructions for use (ifu) supplied with the device.The ifu also states, "bioresorption of the scaffold material will be essentially complete within 18-24 months." note, the date of implant and date of event is estimated as (b)(6) 2020 and 15-jun-2022 respectively, based on the information available.Addendum: h11: this is an addendum to the initial mdr submitted.This supplemental mdr is submitted to report the product identifiers, surgical intervention, implant date and event date.Based on the additional information provided, the initial determination remains the same, no conclusion can be made.Corrected fields: b3 (date of event), d6a (date of implant).Note: section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.H3 other text : not returned - remains implanted.
Event or Problem Description
As reported, the patient was implanted with galaflex in (b)(6) 2020 added to a breast lift.It was reported that immediately after surgery, the patient experienced constant pain.The patient reported the breast lift failed in regardless of the mesh implant, and over the next few months the mesh was seen above the skin.It was also reported that it remained that way for two years post op and the patient is left with pain.The patient also states that after adding implants it has failed further.Addendum as reported, patient underwent mastopexy with internal bra on (b)(6) 2020, during which galaflex 3dr mesh was implanted.It was reported that the patient underwent revision lift on (b)(6) 2021 and on (b)(6) 2022 the patient had 450cc breast augmentation.It was also reported that patient need another breast lift revision.

• Brand Name: GALAFLEX 3DR
• Common Device Name: ABSORBABLE MESH
• Manufacturer (Section D): TEPHA, INC. - 3005670760; 99 hayden ave suite 360; lexington MA 02421
• Manufacturer (Section G): TEPHA, INC. - 3005670760; 99 hayden ave suite 360; lexington MA 02421
• Manufacturer Contact: andrew topoulos ; 100 crossings blvd.; warwick, RI 02886 ; 8005566756
• MDR Report Key: 15500018
• Report Number: 1213643-2022-00631
• Device Sequence Number: 5898426
• Product Code: OOD
• UDI-Device Identifier: 00810054980049
• UDI-Public: (01)00810054980049
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K162922
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 06/22/2021
• Device Model Number: 100043-05
• Device Catalogue Number: FR3D05
• Device Lot Number: 190283
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/02/2022
• Supplement Date Received by Manufacturer: 10/21/2022
• Initial Report FDA Received Date: 09/28/2022
• Supplement Report FDA Received Date: 11/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 34 YR
• Patient Sex: Female